| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | M803050210 | Pessary Cerclage#1 w/drain | 050210 | Pessary Cerclage is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cerclage # 1 w/drain |
| 2 | M803050192 | Pessary Cerclage w/o drain # 2 | 050192 | Pessary Cerclage is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cerclage w/o drain # 2 |
| 3 | M803050172 | Pessary Cup w/support # 1 | 050172 | Cup Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cup w/support # 1 |
| 4 | M803050159 | Pessary Gellhorn w/drain #5 | 050159 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gellhorn w/drain #5 |
| 5 | M803050145 | Pessary Oval w/ support # 0 | 050145 | Gehrung Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gehrung w/ support # 0 |
| 6 | M803050139 | Pessary Dish w/ support # 2 | 050139 | Dish Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Dish w/ support # 2 |
| 7 | M803050135 | Pessary Dish w/o support # 6 | 050135 | Dish Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Dish w/o support # 6 |
| 8 | M803050129 | Pessary Dish w/o support # 0 | 050129 | Dish Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Dish w/o support # 0 |
| 9 | M803050125 | Shaatz w/drain #5 | 050125 | Shaatz Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Shaatz w/drain #5 |
| 10 | M803050083 | Pessary Marland w/o support # 8 | 050083 | Marland Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Marland w/o support # 8 |
| 11 | M803050080 | Pessary Marland w/o support # 5 | 050080 | Marland Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Marland w/o support # 5 |
| 12 | M803050079 | Pessary Marland w/o support # 4 | 050079 | Marland Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Marland w/o support # 4 |
| 13 | M803050078 | Pessary Marland w/o support # 3 | 050078 | Marland Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Marland w/o support # 3 |
| 14 | M803050074 | Pessary Cube w/drain # 8 | 050074 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/drain # 8 |
| 15 | M803050071 | Pessary Cube w/drain # 5 | 050071 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/drain # 5 |
| 16 | M803050067 | Pessary Cube w/drain #1 | 050067 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/drain #1 |
| 17 | M803050059 | Pessary Cube w/o drain # 4 | 050059 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/o drain # 4 |
| 18 | M803050058 | Pessary Cube w/o drain # 3 | 050058 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/o drain # 3 |
| 19 | M803050024 | Pessary Ring w/o support #8 | 050024 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Ring w/o support #8 |
| 20 | M803050023 | Pessary Ring w/o support #7 | 050023 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Ring w/o support #7 |
| 21 | M803050019 | Pessary Ring w/o support #3 | 050019 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Ring w/o support #3 |
| 22 | M803050010 | Pessary Silicone Donut # 0 | 050010 | Pessary Silicone donut is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Silicone Donut # 0 |
| 23 | M803050176 | Pessary Cup w/support # 5 | 050176 | Cup Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cup w/support # 5 |
| 24 | M803050174 | Pessary Cup w/support # 3 | 050174 | Cup Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cup w/support # 3 |
| 25 | M803050171 | Pessary Cup w/support # 0 | 050171 | Cup Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cup w/support # 0 |
| 26 | M803050160 | Pessary Gellhorn w/drain #6 | 050160 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gellhorn w/drain #6 |
| 27 | M803050155 | Pessary Gellhorn w/drain #1 | 050155 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gellhorn w/drain #1 |
| 28 | M803050150 | Pessary Oval w/ support # 5 | 050150 | Gehrung Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gehrung w/ support # 5 |
| 29 | M803050148 | Pessary Oval w/ support # 3 | 050148 | Gehrung Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gehrung w/ support # 3 |
| 30 | M803050147 | Pessary Oval w/ support # 2 | 050147 | Gehrung Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gehrung w/ support # 2 |
| 31 | M803050138 | Pessary Dish w/support # 1 | 050138 | Dish Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Dish w/support # 1 |
| 32 | M803050108 | Pessary Oval w/o support # 8 | 050108 | Oval Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Oval w/o support # 8 |
| 33 | M803050085 | Pessary Marland w/ support # 3 | 050085 | Marland Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Marland w/ support # 3 |
| 34 | M803050081 | Pessary Marland w/o support # 6 | 050081 | Marland Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Marland w/o support # 6 |
| 35 | M803050070 | Pessary Cube w/drain # 4 | 050070 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/drain # 4 |
| 36 | M803050063 | Pessary Cube w/o drain # 8 | 050063 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/o drain # 8 |
| 37 | M803050056 | Pessary Cube w/o drain # 1 | 050056 | Cube Pessary is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cube w/o drain # 1 |
| 38 | M803050027 | Pessary Ring w/support #2 | 050027 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Ring w/support #2 |
| 39 | M803050026 | Pessary Ring w/support #1 | 050026 | Pessary used for to treat uterine prolapse | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Ring w/support #1 |
| 40 | M803050021 | Pessary Ring w/o support #5 | 050021 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Ring w/o support #5 |
| 41 | M803050018 | Pessary Ring w/o support #2 | 050018 | Pessary ring is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Ring w/o support #2 |
| 42 | M803022725 | mini curved | 022725 | iui mini curved | MQF | Catheter, Assisted Reproduction | 2 | MedGyn IUI |
| 43 | M803022724 | mini | 022724 | mini iui | MQF | Catheter, Assisted Reproduction | 2 | MedGyn IUI |
| 44 | M803022720 | endosampler | 022720 | Disposable device for sampling uterine endometrium | BYY | Tube, Aspirating, Flexible, Connecting | 2 | medgyn endosampler |
| 45 | M803TMI6003 | K-UMI Manipulator | TMI6003 | K-UMI Manipulator | LKF | Cannula, Manipulator/Injector, Uterine | 2 | Uterine Manipulator |
| 46 | M803050211 | Pessary Cerclage#2 w/drain | 050211 | Pessary Cerclage is used treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cerclage # 2 w/drain |
| 47 | M803050191 | Pessary Cerclage w/o drain #1 | 050191 | Pessary Cerclage is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cerclage w/o drain #1 |
| 48 | M803050175 | Pessary Cup w/support # 4 | 050175 | Cup Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Cup w/support # 4 |
| 49 | M803050153 | Pessary Oval w/ support # 8 | 050153 | Gehrung Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Gehrung w/ support # 8 |
| 50 | M803050132 | Pessary Dish w/o support # 3 | 050132 | Dish Pessary is used to treat uterine prolapse. | HHW | Pessary, Vaginal | 2 | MedGyn Pessary Dish w/o support # 3 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 57290018240026 | 01 | IL-100-100-100 | Gynescope™ systemconsole for image capturing and digital image archiving | Gynescope, console system | ILLUMIGYN LTD |
| 2 | 40612479200195 | 869 | COLPOSCOPE, CENTER POST LED | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 3 | 40612479200034 | 179 | COLPOSCOPE, BINOC CENTER POST | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 4 | 40612479200027 | 178 | COLPOSCOPE, TRINOCULAR | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 5 | 40612479200010 | 177 | COLPOSCOPE, ARTICULATING ARM | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 6 | 40612479200003 | 164 | COLPOSCOPE, TRINOC CTR POST | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 7 | M803010505 | AL-105Z | 010505 | Swing Arm AL-105 | MedGyn Gynescope (Colposcope) | MEDGYN PRODUCTS, INC. |
| 8 | M803010500 | AL-105 | 010500 | MedGyn Gynescope (Colposcope) | MedGyn Gynescope | MEDGYN PRODUCTS, INC. |
| 9 | M803010469 | AL-106B | 010469 | Video Colposcope | MedGyn Video Colposcope | MEDGYN PRODUCTS, INC. |
| 10 | M803010466SA1 | Swing Arm Video Colposcope | 010466sa | Swing Arm Video Colposcope | medgyn video colposcope | MEDGYN PRODUCTS, INC. |
| 11 | M803010466 | Video Colposcope | 010466 | Video Colposcope | MedGyn Video Colposcope | MEDGYN PRODUCTS, INC. |
| 12 | M803010200 | AL-102 | 010200 | MedGyn Gynescope (Colposcope) | MedGyn Gynescope | MEDGYN PRODUCTS, INC. |
| 13 | M803010198 | AL-401 | 010198 | MedGyn AL-401 Colposcope with Tilt Stand (3-Step Magnification) | MedGyn Gynescope | MEDGYN PRODUCTS, INC. |
| 14 | 17290018240011 | 01 | IL-100-100-000 | GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs | GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs | ILLUMIGYN LTD |
| 15 | 17290016976028 | EVA 3 Plus/EVA 3.1 | The EVA (Enhanced Visual Assessment) System is intended to provide magnified vie The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remoteviewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics. | EVA System | MOBILEODT LTD | |
| 16 | 17290016976011 | 3.0 | The EVA (Enhanced Visual Assessment) System is intended to provide magnified vie The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remoteviewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics. | EVA System | MOBILEODT LTD | |
| 17 | 17290016976004 | 2 | The EVA (Enhanced Visual Assessment) System is intended to provide magnified vie The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remoteviewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics. | EVA System | MOBILEODT LTD | |
| 18 | 10607151011397 | CS-305 | CS-305 | Colposcope Center Post Tri Power - LED | Bovie | BOVIE MEDICAL CORPORATION |
| 19 | 10607151011380 | CS205T-SVM | CS205T-SVM | Colposcope Center Post S-Video Package w/Monitor | Bovie | BOVIE MEDICAL CORPORATION |
| 20 | 10607151011373 | CS-205T-SV | CS-205T-SV | Colposcope Center Post S-Video Package | Bovie | BOVIE MEDICAL CORPORATION |
| 21 | 10607151011366 | CS-205T-SDV | CS-205T-SDV | Colposcope Center Post S-Video Package w/Monitor and Image Grabber | Bovie | BOVIE MEDICAL CORPORATION |
| 22 | 10607151011359 | CS-205T-LED | CS-205T-LED | Colposcope Center Post Trinocular, LED | Bovie | BOVIE MEDICAL CORPORATION |
| 23 | 10607151011342 | CS-205T-DV | CS-205T-DV | Colposcope Center Post Digital Video Package | Bovie | BOVIE MEDICAL CORPORATION |
| 24 | 10607151011335 | CS-205LED | CS-205LED | Colposcope Center Post Binocular, LED | Bovie | BOVIE MEDICAL CORPORATION |
| 25 | 10607151011328 | CS-105T-LED | CS-105T-LED | Colposcope Articulating Arm Trinoc 5 leg, LED | Bovie | BOVIE MEDICAL CORPORATION |
| 26 | 10607151011311 | CS-105LED | CS-105LED | Colposcope Articulating Arm Binoc 5 leg, LED | Bovie | BOVIE MEDICAL CORPORATION |
| 27 | 10607151011304 | CS103T-SVM | CS103T-SVM | Colposcope Articulating Arm S-Video Package w/Monitor | Bovie | BOVIE MEDICAL CORPORATION |
| 28 | 10607151011281 | CS-103T-SV | CS-103T-SV | Colposcope Articulating Arm S-Video Package | Bovie | BOVIE MEDICAL CORPORATION |
| 29 | 10607151011267 | CS-103T-SDV | CS-103T-SDV | Colposcope Articulating Arm S-Video Package w/Monitor and Image Grabber | Bovie | BOVIE MEDICAL CORPORATION |
| 30 | 10607151011243 | CS-103T-LED | CS-103T-LED | Colposcope Articulating Arm Trinoc 3 leg, LED | Bovie | BOVIE MEDICAL CORPORATION |
| 31 | 10607151011236 | CS-103T-DV | CS-103T-DV | Colposcope Articulating Arm Digital Video Package | Bovie | BOVIE MEDICAL CORPORATION |
| 32 | 10607151011229 | CS-103LED | CS-103LED | Colposcope Articulating Arm Binoc 3 leg, LED | Bovie | BOVIE MEDICAL CORPORATION |
| 33 | 07300009046461 | V1 | GYN-0001 | The Gynocular is a colposcope intended to provide magnified visualization for th The Gynocular is a colposcope intended to provide magnified visualization for the tissues of the vagina, cervix and the external genitalia. It Is used to evaluate these tissues and select areas for biopsy. | Gynius | GYNIUS AB |
| 34 | 06944413801868 | C6A | Video Colposcope | EDAN INSTRUMENTS, INC. | ||
| 35 | 06944413801851 | C3A | Video Colposcope | EDAN INSTRUMENTS, INC. | ||
| 36 | 06928798600285 | KN-2200BI | Kernel | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | ||
| 37 | 06928798600278 | KN-2200B | Kernel | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | ||
| 38 | 06928798600261 | KN-2200I(H） | Kernel | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | ||
| 39 | 06928798600254 | KN-2200I | Kernel | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | ||
| 40 | 06928798600247 | KN-2200A | Kernel | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | ||
| 41 | 06928798600230 | KN-2200 | Kernel | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | ||
| 42 | 05060477110188 | DYS403 | DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 6 components; PC, BASE Assembly, Optical ARM Assembly (ARMO), Display ARM Assembly (ARMD), Optical Head Unit and Clinician Touch Screen Monitor. | DYSIS Ultra 2.0 | DYSIS MEDICAL LIMITED | |
| 43 | 05060477110065 | DYS402 - DYSIS Ultra | DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 7 components; PC, BASE Assembly, Optical ARM Assembly (ARMO), Display ARM Assembly (ARMD), Optical Head Unit, Clinician Touch Screen Monitor and Patients Monitor. | DYSIS Ultra | DYSIS MEDICAL LIMITED | |
| 44 | 05060477110027 | MON001 - DYSIS v3 19" Monitor Assembly | DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 3 components; BASE Assembly, ARM Assembly and Monitor. | DYSIS v3 Digital Coploscope | DYSIS MEDICAL LIMITED | |
| 45 | 05060477110010 | DYS302 - DYSIS v3 ARM Assembly | DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 3 components; BASE Assembly, ARM Assembly and Monitor. | DYSIS v3 Digital Colposcope | DYSIS MEDICAL LIMITED | |
| 46 | 05060477110003 | DYS302 - DYSIS v3 BASE Assembly | DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 3 components; BASE Assembly, ARM Assembly and Monitor. | DYSIS v3 Digital Colposcope | DYSIS MEDICAL LIMITED | |
| 47 | 04953170331763 | OCS5-ZB | Zoom microscope body | OLYMPUS MEDICAL SYSTEMS CORP. | ||
| 48 | 04953170331749 | OCS5-TVAD1 | COLPOSCOPE OCS-500 TV CAMERA ADAPTER | OLYMPUS MEDICAL SYSTEMS CORP. | ||
| 49 | 04953170331701 | OCS5-STB | Floorstand base | OLYMPUS MEDICAL SYSTEMS CORP. | ||
| 50 | 04953170331695 | OCS5-STD | Stand | OLYMPUS MEDICAL SYSTEMS CORP. |